Stent trimming devices and methods

ABSTRACT

Devices and methods for trimming a stent to a desired length with an outer tube and an inner tube having a distal end and a diameter configured to receive a portion of the stent in excess of the desired length. The inner tube may move within the outer tube and the distal end may include an end effector configured to trim the portion from the stent while the device and stent are within a patient.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.15/837,596, filed Dec. 11, 2017, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Patent Application Ser. No.62/433,138, filed Dec. 12, 2016, which is incorporated by referenceherein in its entirety and for all purposes.

FIELD

The present disclosure relates generally to medical devices for trimmingmedical stents to a desired length while the stent is within the body ofa patient, and more particularly to devices and methods for trimmingstents placed in the ureter to facilitate drainage from the kidney tothe bladder.

BACKGROUND

Medical devices developed for implantation or insertion into patientsare known for various purposes including stenting, drainage, etc., oflumens, tracts, vessels, and cavities within the body. As an example,polymeric ureteral stents are widely used to facilitate drainage in theupper urinary tract (e.g., drainage from the kidney to the bladder), forexample, following ureteroscopy, endourerotomies, and endopyelotomy forureteral strictures, as well as in other instances where ureteralobstruction may occur.

An exemplary stent 10 of this type is illustrated in FIG. 1. The stent10 has a proximal end 10 p and a distal end 10 d. It is a tubularpolymer extrusion having a shaft 12, a distal renal retention structure(e.g., renal “pigtail” 14), and a proximal retention structure (e.g.,bladder “pigtail” 16). These retention structures prevent upwardmigration of the stent toward the kidney or downward migration of thestent toward the bladder. Once properly deployed in the ureter, thestent 10 provides ureteral support and allows the passage of urine. Thestent 10, as exemplified by FIG. 1, may further be provided with any oneor more of the following: (a) a tapered tip 11, to aid insertion, (b)multiple side ports 18 (one numbered), which are typically arranged in aspiral pattern down the length of the body to promote drainage, (c)graduation marks 25 (one illustrated), which are normally used forvisualization by the physician to know when the appropriate length ofstent has been inserted into the ureter, and (d) a suture 22, which aidsin positioning and withdrawal of the stent.

During placement, such ureteral stents 10 are typically placed over aurology guide wire, through an access sheath, and advanced into positionwith a pusher. Once the distal end of the stent is advanced into thekidney/renal calyx, the guide wire is removed, allowing the pigtails 14,16 to form in the kidney 19 and bladder 20, as shown in FIG. 2. Therenal pigtail 14 of the stent may be closed or tapered on the end,depending on the method of insertion (e.g., the use of a guide wire orotherwise). As shown in FIG. 2, the stent 10 extends through theureteral orifice 21 a and into the bladder 20. The other ureter enteringbladder 20 through the opposite ureteral orifice 21 b is not shown.

These types of implanted medical devices may be associated with patientdiscomfort or pain after being positioned within the body, for example,in regard to ureteral stents, pain and/or discomfort in the bladder andflank area after insertion. Another potential issue is that variousapplications and anatomies require medical devices of differentdiameters and lengths, e.g., differences in individual ureteralanatomies require different diameters and lengths between the endretention structures of ureteral stents. Consequently, hospitals andother facilities inventory stents of different diameters and for eachdiameter, stents of different lengths, in some cases as much as sixstents of different lengths for each diameter.

Generally, a physician must estimate ureter length before beginning aprocedure. If the estimate is near the end of a particular length rangeof stents that are kept on hand, it is possible to select a stent thatis slightly too long or too short. However, that fact may not beascertainable until the stent has been implanted. The procedure forcorrecting any incorrect selection involves removing that stent andplacing a longer or shorter stent in the ureter thereby complicating theprocedure and potentially increasing patient trauma.

Variable length stents include offset, planar, or nautilus coils at oneor both of the end retention structures that can be unwound to increaseor decrease the effective length between the structures. Anotherureteral stent example includes a stent with multi-turn coils at thebladder end that may be clipped off outside of the body when the lengthof the stent has been estimated by the physician.

Although these examples may reduce inventory requirements, excessretention structure left in the bladder may occupy a considerable volumewhich may increase a risk of tissue irritation. Additionally, stentsclipped to length outside of the body prior to placement may ultimatelyresult in a length that is too short, requiring a new stent to be used,or too long, in which case the excess material and irritation concernsremain. Therefore, there exists a need for medical devices and methodsto trim a stent within the patient to ensure that it is sized accuratelyand consistently without excess volume leftover that may causeirritation.

SUMMARY

The present disclosure, in its various aspects, meets an ongoing need inthe medical field, such as the field of ureteral stents, for stenttrimming devices and methods which ensure a proper stent length duringstent positioning within a patient.

A device for trimming a proximal end of a stent to a desired length mayinclude an outer tube with an inner tube having a proximal end, a distalend, and an inner diameter configured to receive an outer diameter of atleast a portion of the proximal end of the stent in excess of thedesired length. The inner tube may be movably disposed within the outertube. The distal end of the inner tube may include an end effectorconfigured to trim the portion from the stent while the device and stentare within a patient.

An embodiment of the disclosure may include an inner tube configured toreceive the portion of the stent only within the end effector at thedistal end of the inner tube. An embodiment may include an inner tubeconfigured to receive the portion of the stent along the entire lengthof the inner tube. An embodiment may include an end effector with anopened and closed configuration. An embodiment may include an endeffector that has two or more arms biased away from a longitudinal axisof the device in the opened position. An embodiment may include an outertube that movably encompasses the end effector in the closedconfiguration of the inner tube. An embodiment may include a stent thatis a ureteral stent, where the proximal end includes a distal tip with abladder retention segment, and the trimmed stent portion comprises aportion of the distal tip.

An embodiment of the disclosure for trimming a proximal end of a stentto a desired length may include an outer tube and an inner tube movablydisposed within the outer tube. The inner tube may have a proximal endand a distal end. The distal end may be configured to trim a portion ofthe proximal end of the stent in excess of the desired length in vivo.

An embodiment of the present disclosure may include a tip extended froma distal end of the outer tube. The tip may include a window having anopening along a side surface of the outer tube substantiallyperpendicular to a longitudinal axis of the outer tube. The window maybe configured to receive at least the portion of the stent. The innertube may have a sharpened edge at the distal end of the inner tube,whereby relative movement of the inner tube with respect to the outertube engages the sharpened edge with the tip.

An embodiment of the present disclosure may include a tip with a postdisposed within the tip. The post may have a beveled proximal faceangled toward the window opening.

An embodiment of the present disclosure may include a pair of inner armsextended from the distal end of the inner tube and biased toward eachother in the direction of the longitudinal axis. The pair of inner armsmay each include a first inward facing tab with a pair of notches. Anembodiment may include a pair of outer arms extended from the outer tubeand biased toward each other in the direction of the longitudinal axis.The pair of outer arms may each include a pair of second inward facingtabs configured to engage a notch on the first inward facing tabs ofeach inner arm on opposing sides of the inner tube. The outer arms mayinclude a pair of fingers extending inwardly from the pair of outerarms.

An embodiment may include a distal end of the inner tube with threesplayed arms, each with a sharpened edge pointed substantially inwardtoward a longitudinal axis of the inner tube. An embodiment may includea first aperture near a distal end of the outer tube that issubstantially perpendicular to a longitudinal axis of the outer tube.The inner tube may include a second aperture near the distal end of theinner tube that is substantially perpendicular to a longitudinal axis ofthe inner tube with at least one sharp edge, the inner tube and outertube being rotatable with respect to each other to engage the inner tubeedge. An embodiment may include an inner tube with a concentric internalshelf on the inside of the inner tube of a smaller diameter than theinner tube and further. A third tube may be removably disposed withinthe distal end of the inner tube. The third tube may include an openingconfigured to receive at least the portion of the stent to be trimmedand a plurality of blades at a distal end of the third tube that areconcentrically spaced apart from each other around the opening, andwherein the outer tube tapers down to a smaller diameter at a distalend. The inner tube may have outer threads on an outer surface at thedistal end of the inner tube and wherein the outer tube has innerthreads on an inner surface at the distal end of the outer tube thatengage the outer threads on the inner tube.

A method of trimming a stent of the present disclosure may includeintroducing a stent into a patient. The method may include introducing astent trimming device into the patient. The method may include measuringa portion of the stent to be trimmed. The method may include trimmingthe portion within the patient with the stent trimming device. Themethod may include measuring the portion through an aperture of thedevice. The method may include trimming the portion by moving an innertube relative to an outer tube of the device. The method may includeintroducing the stent and introducing the stent trimming devicesimultaneously.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting examples of the present disclosure are described by way ofexample with reference to the accompanying figures, which are schematicand not necessarily drawn to scale. In the figures, each identical ornearly identical component illustrated is typically represented by asingle numeral. Not every component is labeled in every figure, nor isevery component of each embodiment of the disclosure shown whereillustration is not necessary to allow those of skill in the art tounderstand the disclosure. In the figures:

FIG. 1 is an illustration of a ureteral stent, according to the priorart.

FIG. 2 is an illustration of a prior art ureteral stent, like that ofFIG. 1, positioned in the body.

FIG. 3 illustrates an example embodiment of a medical device fortrimming a stent, wherein the device is shown engaging a stent fortrimming.

FIG. 4A illustrates an example embodiment of a medical device fortrimming a stent.

FIGS. 4B-4C illustrate a closer view of the window for stent andguidewire ingress and egress of the example embodiment of a medicaldevice for trimming a stent of FIG. 4A.

FIG. 4D illustrates an example embodiment of a medical device fortrimming a stent.

FIG. 4E illustrates an example embodiment of a medical device fortrimming a stent.

FIG. 5A illustrates a top view of an outer tube of an example embodimentof a medical device for trimming a stent.

FIG. 5B illustrates a side view of an inner tube of an exampleembodiment for trimming a stent.

FIG. 6A illustrates an example embodiment of a medical device fortrimming a stent.

FIG. 6B illustrates a closer view of the stent trimming device of FIG.6A.

FIG. 7A illustrates an example embodiment of a medical device fortrimming a stent.

FIG. 7B illustrates a closed configuration of the stent trimming deviceof FIG. 7A.

FIG. 8 illustrates an example embodiment of a medical device fortrimming a stent.

FIG. 9 illustrates an example embodiment of a medical device fortrimming a stent.

FIG. 10A illustrates an inner tube of an example embodiment of a medicaldevice for trimming a stent.

FIG. 10B illustrates an outer tube of an example embodiment of a medicaldevice for trimming a stent.

FIG. 10C illustrates a third tube of an example embodiment of a medicaldevice for trimming a stent.

FIG. 11A illustrates an inner tube of an example embodiment of a medicaldevice for trimming a stent.

FIG. 11B illustrates an inner tube and a third tube of an exampleembodiment of a medical device for trimming a stent.

FIG. 11C illustrates an assembly of the components of FIGS. 11A and 11B.

FIG. 11D illustrates an outer tube added to the assembly of FIG. 11C.

FIG. 11E illustrates a cross-sectional view of the assembly of FIG. 11D.

FIG. 12 is a diagram of a method for trimming a stent.

It is noted that the drawings are intended to depict only typical orexemplary embodiments of the disclosure. Accordingly, the drawingsshould not be considered as limiting the scope of the disclosure. Thedisclosure will now be described in greater detail with reference to theaccompanying drawings.

DETAILED DESCRIPTION

Devices, systems and methods in accordance with various embodiments ofthe present disclosure include medical devices capable of trimming astent in vivo. The devices include an inner elongated tubular memberhaving a lumen extending along a length thereof. The devices alsoinclude an outer elongated tubular member having a lumen extending alonga length thereof. The members may be semi-flexible along the length. Thedistal end of the devices is configured to trim a stent in vivo in orderto achieve a stent of a desired length.

Various embodiments according to the present disclosure are describedbelow. As used herein, “proximal end” refers to the end of a device thatlies closest to the medical professional or outside the urethral exit(downstream) in the case of a ureteral stent, and “distal end” refers tothe end of an implanted or positioned device or object that liesfurthest from the medical professional or urethral exit (upstream) whenused in the context of a ureteral stent.

The various embodiments of adjustable length medical devices (e.g.,stents) which may be trimmed according to embodiments of devices andmethods of the present disclosure, including as described above andbelow, may have any of the following features. Devices, particularly inthe context of a ureteral stent, may have an outer diameter of about 3French to about 9 French, including any half or whole size within thatrange, and may have an inner diameter of about 0.038 inches (about 0.097cm) to accommodate the profile of standard medical guidewires within thelumen of the tubular member. Embodiments of ureteral stents useful fordevices and methods of the present disclosure may have an adjustablelength of about 10 cm to about 35 cm as measured between the retentionmembers.

In a ureteral stent implantation procedure, a guidewire is fed into thebladder, then into the ureter, past the renal pelvis, and into thekidney. A stent may then be guided over the guidewire along the samepath so that it may be positioned from the kidney to the bladder alongthe ureter. Once in position, the guidewire may be withdrawn, leavingthe stent implanted in the patient as illustrated in the prior art ofFIG. 2. It is desirable for the patient to receive an implanted stent ofcomfortable length. Too long of a stent may cause undesirable irritationto the patient. Too short, and the stent may migrate out of position andcease to function properly. Adult patients typical require ureteralstents with a length of about 10 cm (3.9 in) to about 35 cm (13.8 in.)as measured between the retention members. A stent with retentionmembers (e.g. pigtails) may add about 10 cm to about 15 cm of additionallength. Rather than estimate stent lengths, it would be preferable for amedical professional to trim a stent in vivo within a patient to tailorthe length to their body's dimensions.

The stents with which various embodiments of trimming devices of thepresent disclosure may be used, alone or as system or kit along with astent, may contain one or more optional additives, for example, selectedfrom therapeutic agents, radiopaque agents, colorants, other optionaladditives such as plasticizers and extrusion lubricants, andcombinations of the above, among others, in amounts effective to servetheir intended purposes. Where used, such optional additives may bepresent, for example, in polymeric, among others, or in coatings appliedto the polymeric materials, or both.

Radiopaque agents facilitate viewing of the medical device duringinsertion of the device and at any point while the device is implanted.Among radiopaque agents useful in the medical devices of the presentdisclosure are included bismuth salts such as bismuth subcarbonate,bismuth oxychloride, bismuth trioxide, barium sulfate, tungsten, andmixtures thereof. More specific examples of such radio-opaque agentsinclude tungsten, platinum, tantalum, iridium, gold, or other densemetal, barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuthoxychloride, metrizamide, iopamidol, iothalamate sodium, iodomidesodium, and meglumine, among others. Where present, the radiopaque agentis typically present in an amount of from about 10% to about 40%(including 10% to 15% to 20% to 25% to 30% to 35% to 40%, with 15-30%being more typical). Additionally or alternatively, the polymericmaterial or additive material choice, as well as extrusion technique,may be optimized to enhance device contrast using ultrasound imaging.The incorporation of sonographic agents, in addition to or as analternative to radiopaque agents, such as contrast beads or foams, amongother examples, facilitate viewing of the medical device underultrasonic imaging during insertion of the device and at any point whilethe device is implanted. One skilled in the art can readily determine anappropriate radiopaque and sonographic agent content to achieve thedesired visibility. The polymer materials described may be mixed withthe radiopaque and/or the sonographic agents above, or a colorant. Acolorant may be used as a visual cue to a medical professional about thelocation of the medical device in the patient. Graduated markings on thestent may assist the medical professional with measuring a length ofstent to trim.

With reference to FIG. 3, for example, a stent 302 may be guided over aguidewire 304 thereby straightening any retention members of the stentalong the wire within a patient. The stent slides along the guidewire,alone or is carried on a catheter or other delivery device that the wireextends through. The guidewire, if used alone, may be sufficiently stiffto hold the retention members straight while the guidewire is in thelumen of the stent. An outer pusher member slidably coaxial with aninner member of a delivery device, or with a wire if used alone, may beused to abut the proximal end of the stent and push the stent distally.A radiopaque or sonographic band, filler or other marker as part of thepusher and/or delivery device allows a medical professional to view thepusher and/or device on a fluoroscope or using ultrasound. Additionally,if the stent is radiopaque or sonovisible, placement of the stent in thepatient may be confirmed by viewing the stent on a fluoroscope or byusing ultrasound. Once positioned at the distal end of the placementpoint, the guidewire alone or in conjunction with a delivery device, ifused, is withdrawn from the lumen of the distal (or kidney, in the caseof a ureteral stent) retention member. If a pusher is used, the pusherholds the stent in place while the guidewire or guidewire and innermember of the delivery device is removed. The shape-memory of theretention member allows the retention member to return to its shapememory configuration, such as a pigtail coil.

As the guidewire and/or delivery device is withdrawn into, for example,the bladder in the case of a ureteral stent, the medical professionalsights the bladder retention member and proximal portion including anygraduated markings corresponding to incremental portions along thelength thereof. If included, the graduated marking that approximates thedesired length of the stent extending along the ureter at the placementpoint of the proximal retention member, e.g., the bladder retentionmember, may be identified.

Once the desired length is identified (with or without the aid ofgraduated markings), the stent may be adjusted by trimming the stent atthe incremental portion that corresponds to the excess of the desiredlength. The medical professional may movably operate the inner and outertubes of the trimming device by grabbing the handle or handles of thedevice and moving, sliding, and/or rotating the tubes. Trimming may bedone in the absence of graduated markings, as long as there is a way todetermine the amount of excess stent to be trimmed from the desiredlength. Divots, holes, perforations, or the like, within and along thestent wall may make the stent easier to trim. The trimming may be donewith a medical device or with a tool that is integrated therewith, whilethe stent is on a guidewire or within a delivery device, in accordancewith embodiments described herein. Various embodiments of trimmingdevices in accordance with the present disclosure are contemplated assuitable to engage and trim a stent or other medical device at a desiredlength, utilizing some form of trimming mechanism with a sharpened edgeand applied pressure, such as cutting blades, cutting wires, heatedwires or blades, grasping, punching, crimping or pinching mechanisms, orthe like. Heated tools may include a mold to form a taper on the end ofthe tubular member after the incremental portion is trimmed from theremainder of the stent.

Trimming may be accomplished while a stent is still in a straightenedconfiguration on the guidewire or delivery device, or after a guidewirealone or in conjunction with a delivery device, if used, is withdrawnfrom the lumen of a proximal (or bladder, in the case of a ureteralstent) retention member and the retention member assumes its shapememory form, such as a multi-turn planar coil. The trimmed incrementalportion may be removed from the bladder by various means.

A tapered tip on the distal retention member can facilitate inserting astent through the passages of a patient's body. Additionally, a sutureon a stent can be used to reposition the stent (by pulling on it) wheninserting the stent, and a suture may be used to remove the stent fromthe patient after some period of use, provided the suture is secured toa portion of the stent above any incremental portion that may betrimmed. When the stent is to be removed, the medical professional maypull on the suture to remove the stent. However, other means may be usedto remove the stent.

A medical device for trimming a stent 306 may be guided over theguidewire 304 so that the distal end of the device 306 may receive anyexcess portion of the stent 302 that the medical professional determinesis additional unnecessary length of the stent 302. An end effector ofthe distal end of the device 306 may be configured to trim the excessportion of the stent 302 of a desired length of the stent 302. Theexcess portion of stent 302 may be withdrawn from the patient along withthe device 306.

Alternatively, with reference to FIG. 3, the medical device for trimminga stent may be guided over the guidewire 304 and the stent 302 may beguided over the guidewire 304 and through the device 306. The stent 302may be fed out of the distal end of the device 306. A desirable lengthof stent 302 may be measured by the medical professional, and any excessportion of stent 302 may be separated by the trimming mechanism of thedistal end of device 306. The excess portion of stent 302 may bewithdrawn from the patient along with the device 306.

A medical professional may measure a tailored length of a stent for eachpatient before trimming away any excess length. This may be performedwhile the medical professional is positioning the stent via fluoroscopy.A tip of the medical device may be radiopaque so that the medicalprofessional may visually see via fluoroscopy where the trimming tip ofthe device is located within the patient to trim the excess stent at anappropriate length. Alternatively, a ureteroscope or other type ofcamera may be used by the medical professional to measure and trim anappropriate length of the stent.

With reference to FIG. 4A, an embodiment of the disclosure may includean outer tube 402 with an inner tube 404 that can movably slide withinthe outer tube 402. The distal end of the outer tube 402 may have a tip406 extended from the distal end of the outer tube 402. The tip 406 mayinclude a window 410 having an opening along a side surface of the outertube 402 substantially perpendicular to a longitudinal axis of the outertube 402. The window 410 is configured to receive at least a portion ofthe stent. The inner tube 404 may slide into the tip 406. The window 410of outer tube 402 may create an area of egress in the outer tube for aguidewire (not shown) and/or a stent 408.

Referring to FIG. 4B, the outer tube 402 may have a bevel 412 with aface that is angled at about 45° to the direction of the window 410, orangled at different angles as desired. A guidewire and/or stent may bedeflected out and away from outer tube 402 by being directedtangentially by the face of the bevel 412. The length of the stent 408may be measured by translating the stent 408 within the inner tube 404.Additionally or in the alternative, the entire medical device 400 may betranslated in relation to the stent 408 in order to measure anappropriate length of the stent 408 to be positioned and implanted inthe patient. Once measured, the stent 408 may be trimmed by translatingthe inner tube 404 distally in relation to the outer tube 402 into thetip 406. Referring to FIG. 4C, the inner tube 404 may slide over thebevel 412 and inside the edge 414 of the window 410. The bevel 412prevents the stent (not shown) from being pushed into the tip 406 fromthe compressing force of the translation of the inner tube 404. Thebevel 412 and the edge 414 assist the inner tube 404 in trimming thestent (not shown).

Referring to FIGS. 4D and 4E, a cutting edge or edges 416 may exist onthe distal end of the inner tube 404 and/or in addition to a cuttingedge or edges on the bevel 412. Trimming of the stent 408 may beperformed by the translation of the inner tube 404 and/or the rotationof the inner tube 404 relative to the outer tube 402.

Referring to FIGS. 5A and 5B, an example embodiment of a trimming deviceof the disclosure may include an outer tube 502 with outer arms 506 atthe distal end. The arms 506 are biased toward each other. Inner tube504 may have inner arms 512 that are biased toward each other. Each ofthe inner arms 512 may include a first inward facing tab with a pair ofnotches, while each pair of outer arms 506 may include a pair of secondinward facing tabs configured to engage a notch on the first inwardfacing tabs of each inner arm 512 on opposing sides of the inner tube504. The outer arms 506 may also include a pair of fingers extendinginwardly. The manner in which these inner arms 512 and outer arms 506interact will be discussed with reference to FIGS. 6A and 6B. Inner tube604 may movably slide into outer tube 602 such that the inner arms 612and the outer arms 606 engage each other. When the arms engage eachother, the inner arms 612 are deflected outwards when the outer tabs 608engage the notches 616 on the inner tabs 614. Additionally, as the innerarms 612 engage the outer arms 606, the outer arms are deflectedoutwards when the inner tabs 614 engage the outer tabs 608. With theinner arms 612 and outer arms 606 in an outwardly deflected state, astent (not shown) may be received by the distal end of the tubes. Amedical professional may measure out an appropriate length of stent tobe positioned within a patient before deciding to trim the excess amountof the stent. When the medical professional moves the inner tube 604proximally, the notches 616 slide over the outer tabs 608 until theydisengage from the outer tabs 608 completely. At this point the innerarms 612 and outer arms 606 transition into a collapsed state since thearms are biased towards each other. As the inner arms 612 collapsetowards each other, inner tabs 614 pinch the stent at a location betweenthe fingers 610 of the outer tube 602. These fingers 610 may also pinchthe stent in the collapsed state of the tubes. As the inner tube 604 istranslated proximally, tensile stress is applied to the stent at thepinching point between the four edges of the inner tabs 614 and thefingers 610. Continued application of tensile stress to the stent willtrim the excess portion of the stent. The excess portion of the stentand the inner tube 604 may be drawn proximally through the outer tube602 and away from the stent's positioning site. Gaps may be allowedbetween each of the inner tabs 614 and the fingers 610 wide enough for aguidewire to remain without being pinched in the collapsed state.

Referring to FIGS. 7A and 7B, an embodiment of a trimming device of thepresent disclosure may include an outer tube 702 and an inner tube 704that may movably translate into the outer tube 702. The inner tube 704may have three arms 706 splayed at its distal end. The three arms 706may each have a sharpened edge, e.g., blade 708, that is directedinwardly. The splayed arms 706 will close towards each other when theinner tube 704 is translated relative to the outer tube 702. In theinner tube's 704 closed state, a window 710 is vacant to allow for thedevice 700 to be guided along a guidewire (not shown). When the device700 reaches the stent (not shown), the inner tube 704 may be translatedthrough the outer tube 702 distally so that the members 706 splay opento receive an excess portion of the stent. The inner tube 704 may thenbe translated relative to the outer tube 702, collapsing the members 706towards each other. The blades 708 on the members 706 may then score thestent. The stent may be trimmed by the collapsing bladed members 706and/or by additional rotational force of the inner tube 704.

Referring to FIG. 8, an embodiment of the disclosure may include anouter tube 802 with an inner tube 804 that may movably translate intoand relative to the outer tube 802. The inner tube 804 may have two arms806 splayed at its distal end. The two arms 806 may include one or moresharpened edges, e.g., blades 808, that is/are directed inwardly. Thesplayed members 806 will close towards each other when the inner tube804 is translated proximally through the outer tube 802. In the innertube's 804 closed state, a window 810 is vacant to allow for the device800 to be guided along a guidewire (not shown). When the device 800reaches the stent (not shown), the inner tube 804 may be translatedthrough the outer tube 802 distally so that the members 806 splay opento receive an excess portion of the stent. The inner tube 804 may thenbe translated proximally, collapsing the members 806 towards each other.The one or more blades 808 on the members 806 may then score the stent.The stent may be trimmed by the collapsing bladed members 806 or byadditional rotational force of the inner tube 804.

Referring to FIG. 9, an example embodiment of the disclosure may includean outer tube 902 with an inner tube 904 that may slide into the outertube 902. The outer tube 902 may have a rigid tip 906 with a window 908.The inner tube 904 may have a cutout 910 with at least one edge 912along the cutout 910. When the cutout 910 is aligned with the window908, a guidewire and/or a stent may pass through the device 900 (notshown). A medical professional may trim an excess portion of stent byrotating the inner tube 904 relative to the outer tube 902. The stent istrimmed by an edge 912 of the cutout 910 compressing the stent againstthe border of the window 908. The excess stent may be withdrawn from thestent placement site by withdrawing the inner tube 902 or the entiredevice 900.

Referring to FIGS. 10A-10C, an example embodiment of the disclosure mayinclude an inner tube 1004 that may have a concentric internal shelf1012 on the inside of the inner tube 1004 of a smaller diameter than theinner tube 1004. The inner tube 1004 may include outer threads 1014 onits distal end. An embodiment may also include an outer tube 1002 thatmay have inner threads 1016 at its distal end that engage the outerthreads 1014 of the inner tube 1004. The outer tube 1002 may taper downto a smaller diameter at a distal end 1018. An embodiment may include abladed tube 1010 that may split into concentric fingers 1006. The distalend of the bladed tube 1010 may include blades that may beconcentrically spaced apart.

Referring to FIGS. 11A-11E, bladed tube 1010 may slide into inner tube1004 until it is stopped by the internal shelf 1012. FIG. 11Cillustrates the combination of the bladed tube 1010 slid into the innertube 1004. This assembly shown in FIG. 11C may be screwed into the outertube 1002, as shown in FIGS. 11D and 11E. The three tubes result in adevice 1100 that is ready to receive a stent for trimming. The bladedtube 1010 may receive a stent while within the inner tube 1004 and theouter tube 1002, or a stent may be passed through device 1100 from itsproximal end and out of its distal end. A medical professional maymeasure at what point the stent should be trimmed by moving the distalend of device 1100 along the stent. To trim the stent, the inner tube1004 may be rotated while inside the outer tube 1002 so that the outerthreads 1014 engage the inner threads 1016. Alternatively, the outertube 1002 may be rotated against the inner tube 1004, or the tubes maybe rotated against each other to engage the threads. As the threads areengaged, the inner tube 1004 will be driven distally within the outertube 1002. The bladed tube 1010 will also be driven distally within theouter tube 1002 as the inner shelf 1012 pushes the bladed tube 1010 asthe inner tube 1004 moves distally. The bladed tube 1010 will movedistally until it reaches the tapered distal end 1018 of the outer tube1002, at which point the blades 1008 will be compressed radially towardsthe center of the bladed tube 1010.

This blade compression trims the stent at the desired location in vivo.While the threads of the tubes provide control and prevent accidentaltrimming of the stent while in use, an alternative embodiment may trimthe stent by compressing the inner tube 1004 containing the bladed tube1010 against the taper 1018 without the use of threads 1014 and 1016.This would be achieved by pulling the outer tube 1002 proximally againstthe inner tube 1004, and collapsing the blades 1008. An embodiment mayinclude a protective tubular sheath that covers the blades 1008 andprotects the stent. The sheath may be retracted prior to trimming thestent.

Referring to FIG. 12, a method 1200 of using one or more of the above orother various embodiments of the present disclosure may include amedical professional who may introduce 1202 a stent into a patient. Themedical professional may introduce 1204 a stent trimming deviceembodiment of the disclosure into the patient. Alternatively, thetrimming device may be introduced 1204 at the same time as the stent1202. The medical professional may measure 1206 a portion of the stentto be trimmed. The medical professional may trim 1208 the portion to betrimmed within the patient. The medical professional may withdraw theportion and the device from the patient.

Devices according to the embodiments described, and in accordance withother embodiments of the present disclosure, alone or in a system or kitor as part of a method or procedure, including with other accessories,may be used in cavities, lumens, tracts, vessels and organs of the body,aside from stenting the ureter, such as procedures to drain, access orotherwise treat or diagnose conditions in the peritoneal, abdominal,bronchial or thoracic cavities, vascular vessels, gastrointestinal orurinary tract, uterus, bladder, lung and liver organs, etc.

What is claimed is:
 1. A device for trimming a proximal end of a stentto a desired length, comprising: an outer tube; and an inner tube havinga proximal end, a distal end, and an inner diameter configured toreceive an outer diameter of at least a portion of the proximal end ofthe stent in excess of the desired length, the inner tube movablydisposed within the outer tube, the distal end of the inner tubeincluding an end effector configured to trim the portion from the stentwhile the device and stent are within a patient, wherein the endeffector has an opened and closed configuration, and wherein the endeffector has two or more arms biased away from a longitudinal axis ofthe device in the opened position.
 2. A device for trimming a proximalend of a stent to a desired length, comprising: an outer tube; and aninner tube movably disposed within the outer tube, the inner tube havinga proximal end and a distal end, the distal end configured to trim aportion of the proximal end of the stent in excess of the desired lengthin vivo; and (a) wherein the device further comprises a tip extendedfrom a distal end of the outer tube, the tip including a window havingan opening along a side surface of the outer tube substantiallyperpendicular to a longitudinal axis of the outer tube, the windowconfigured to receive at least the portion of the stent; and a sharpenededge at the distal end of the inner tube, whereby relative movement ofthe inner tube with respect to the outer tube engages the sharpened edgewith the tip or (b) wherein the device further comprises a pair of innerarms extended from the distal end of the inner tube and biased towardeach other in the direction of the longitudinal axis, each with a firstinward facing tab with a pair of notches; and a pair of outer armsextended from the outer tube and biased toward each other in thedirection of the longitudinal axis, each with a pair of second inwardfacing tabs configured to engage a notch on the first inward facing tabsof each inner arm on opposing sides of the inner tube or (c) wherein thedevice further comprises a first aperture near a distal end of the outertube that is substantially perpendicular to a longitudinal axis of theouter tube; and a second aperture near the distal end of the inner tubethat is substantially perpendicular to a longitudinal axis of the innertube with at least one sharp edge, the inner tube and outer tube beingrotatable with respect to each other to engage the inner tube edge or(d) wherein the inner tube has a concentric internal shelf on the insideof the inner tube of a smaller diameter than the inner tube and furthercomprising a third tube removably disposed within the distal end of theinner tube, the third tube including an opening configured to receive atleast the portion of the stent to be trimmed and a plurality of bladesat a distal end of the third tube that are concentrically spaced apartfrom each other around the opening, and wherein the outer tube tapersdown to a smaller diameter at a distal end.
 3. The device of claim 2,wherein the device further comprises: a tip extended from a distal endof the outer tube, the tip including a window having an opening along aside surface of the outer tube substantially perpendicular to alongitudinal axis of the outer tube, the window configured to receive atleast the portion of the stent; and a sharpened edge at the distal endof the inner tube, whereby relative movement of the inner tube withrespect to the outer tube engages the sharpened edge with the tip. 4.The device of claim 3, wherein the tip includes a post disposed withinthe tip, the post having a beveled proximal face angled toward thewindow opening.
 5. The device of claim 2, wherein the device furthercomprises: a pair of inner arms extended from the distal end of theinner tube and biased toward each other in the direction of thelongitudinal axis, each with a first inward facing tab with a pair ofnotches; and a pair of outer arms extended from the outer tube andbiased toward each other in the direction of the longitudinal axis, eachwith a pair of second inward facing tabs configured to engage a notch onthe first inward facing tabs of each inner arm on opposing sides of theinner tube.
 6. The device of claim 5, further comprising a pair offingers extending inwardly from the pair of outer arms.
 7. The device ofclaim 2, wherein the distal end of the inner tube comprises threesplayed arms, each with a sharpened edge pointed substantially inwardtoward a longitudinal axis of the inner tube.
 8. The device of claim 2,wherein the device further comprises: a first aperture near a distal endof the outer tube that is substantially perpendicular to a longitudinalaxis of the outer tube; and a second aperture near the distal end of theinner tube that is substantially perpendicular to a longitudinal axis ofthe inner tube with at least one sharp edge, the inner tube and outertube being rotatable with respect to each other to engage the inner tubeedge.
 9. The device of claim 2, wherein the inner tube has a concentricinternal shelf on the inside of the inner tube of a smaller diameterthan the inner tube and further comprising a third tube removablydisposed within the distal end of the inner tube, the third tubeincluding an opening configured to receive at least the portion of thestent to be trimmed and a plurality of blades at a distal end of thethird tube that are concentrically spaced apart from each other aroundthe opening, and wherein the outer tube tapers down to a smallerdiameter at a distal end.
 10. The device of claim 9, wherein the innertube has outer threads on an outer surface at the distal end of theinner tube and wherein the outer tube has inner threads on an innersurface at the distal end of the outer tube that engage the outerthreads on the inner tube.
 11. A method of trimming a stent comprising:introducing a stent into a patient; introducing a stent trimming deviceinto the patient; measuring a portion of the stent to be trimmed; andtrimming the portion within the patient with the stent trimming device,wherein introducing the stent and introducing the stent trimming deviceare performed simultaneously.
 12. The method of claim 11, whereintrimming the portion is performed by moving an inner tube relative to anouter tube of the device.